Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

K152679 · Bio-Rad Laboratories · PMN · May 10, 2016 · Microbiology

Device Facts

• Record ID: K152679
• Device Name: Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
• Applicant: Bio-Rad Laboratories
• Product Code: PMN · Microbiology
• Decision Date: May 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Indications for Use

Amplichek I is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatiis B Virus (HBV) and Hepatitis C Virus (HCV) for molecular diagnostic platforms listed in the package insert. This product is not intended to replace manufacturer controls provided with the device. This product is not intended for use with blood donor screening assays in U.S. or Canada.

Device Story

Amplichek I is an external assayed quality control material for monitoring performance of in vitro nucleic acid testing (NAT) for HIV-1, HBV, and HCV. Input consists of four levels of liquid material (negative and three positive levels) derived from human plasma, containing purified viral preparations, proteins, antimicrobial agents, and stabilizers. Used in clinical laboratories; operated by laboratory personnel. Device provides lot-specific means and ranges for analytes on various molecular diagnostic platforms. Healthcare providers use output to verify assay performance and establish internal quality assurance programs. Does not replace manufacturer-provided controls. Benefits include standardized monitoring of test accuracy and precision for viral load assays.

Clinical Evidence

Bench testing only. Stability studies performed to validate shelf life (16 months at -20°C to -70°C) and open-vial stability (7 days or 3 vial entries at 2°C to 8°C). No clinical data provided.

Technological Characteristics

Liquid quality control material; human plasma-based matrix; contains 0.09% sodium azide preservative and stabilizers. Four levels (negative, L1, L2, L3). Packaged in 1.2 mL vials. Storage: -20°C to -70°C. Not a standard; intended for use with quantitative molecular diagnostic platforms.

Indications for Use

Indicated for use as an external assayed quality control material to monitor performance of in vitro laboratory nucleic acid testing procedures for quantitative detection of HIV-1, HBV, and HCV. Not for use in blood donor screening assays in the U.S. or Canada.

Regulatory Classification

Identification

An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.

Special Controls

An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; (ii) Expected values; (iii) Analyte source; (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays; (C) Stating if the material is a surrogate control; and (D) The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.” (iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”

Predicate Devices

• Amplichek II (DEN150058)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 10, 2016

Bio-Rad Laboratories Maria Zeballos Regulatory Affairs Representative 9500 Jeronimo Road Irvine, CA 92614

Re: k152679

Trade/Device Name: Amplichek I Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: April 11, 2016 Received: April 11, 2016

Dear Ms. Zeballos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Stephen J. Lovell -S for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) k152679

Device Name Amplichek I

### Indications for Use (Describe)

Amplichek I is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatiis B Virus (HBV) and Hepatitis C Virus (HCV) for molecular diagnostic platforms listed in the package insert. This product is not intended to replace manufacturer controls provided with the device. This product is not intended for use with blood donor screening assays in U.S. or Canada.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] Fax: [phone]

### Contact Person

Maria Zeballos Regulatory Affairs Representative IV Telephone: [phone]

### Date of Summary Preparation

April 4, 2016

#### 2.0 Device Identification

| Product Trade Name: Amplichek I | |
|-------------------------------------|-------------------------------------------------------------------|
| Common Name: | Assayed quality control material for clinical microbiology assays |
| Classifications: | Class II |
| Product Code: | PMN |
| Regulation Number: | 21 CFR 866.3920 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Amplichek II Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 DEN150058

#### 4.0 Description of Device

Amplichek I is a set of quality controls consisting of four levels filled in individual vials with 1.2 mL of material. Each level is packaged separately in configuration of 10 tubes per box and four tubes per box in a MiniPak (trial size).

This product is prepared from normal human plasma based material non-reactive to HIV-1 Ribonucleic Acid (RNA), HBV Deoxyribonucleic Acid (DNA) and HCV Ribonucleic Acid (RNA) with added proteins from human sources, antimicrobial agents as preservatives, and stabilizers.

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The positive levels are prepared using purified preparations of HIV, HBV and HCV isolated from human plasma or grown in cell cultures and are reactive for HIV-1 RNA, HBV DNA and HCV RNA.

Amplichek I contains human plasma and purified retroviral and viral hepatitis materials derived from human plasma and/or cultured human cell line sources. Each human unit used in the preparation of this product is tested using licensed reagents and must be found to be non-reactive to HBsAg, antibodies to HIV-1 and HIV-2 and antibodies to HCV. Retroviral and viral hepatitis materials derived from human plasma and/or cultured human cell line sources are treated to inactivate infectious agents. However, no known test method can assure that products derived from human sources will not transmit infection. The labeling recommends that this product and all human specimens be handled in accordance with Biosafety Level 2 practices as described in the United States Department of Health and Human Services Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), Biosafety in Microbiological and Biomedical Laboratories, or other equivalent guidelines.

The package insert will provide lot specific mean and ranges for each analyte on various platforms. The assigned values listed in the proposed package insert were generated in the same manner as used for unknown specimens using FDA approved commercial test kits. The negative control reports qualitative results. The means for the positive controls were calculated from the total laboratory data generated for each analyte on the specific platform and the 3SD range was then assigned. The Amplichek I labeling recommends that each laboratory establish its own acceptable range for each analyte. Procedures for implementing a quality assurance program and monitoring test performance on a routine basis must be established by each individual laboratory.

Amplichek I product should not be used as a standard. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as quides.

#### 5.0 Intended Use

Amplichek I is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) for molecular diagnostic platforms listed in the package insert. This product is not intended to replace manufacturer controls provided with the

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device. This product is not intended for use in blood donor screening assays in the US or Canada.

#### 6.0 Comparison of the new device with the Predicate Device

Bio-Rad Laboratories Amplichek I claim substantial equivalence Bio-Rad's Amplichek II (DEN 150058) currently in commercial distribution. The Table below contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

| Characteristics | Bio-Rad<br>Amplichek I<br>(New Device) | Bio-Rad<br>Amplichek I<br>DEN 150058 |
|-----------------|----------------------------------------|--------------------------------------|
|-----------------|----------------------------------------|--------------------------------------|

| Characteristics | (New Device) | DEN 150058 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Amplichek I is intended for use as an external assayed quality<br>control material to monitor the performance of in vitro laboratory<br>nucleic acid testing procedures for the detection of Human<br>Immunodeficiency Virus Type 1 (HIV-1), Hepatitis B Virus (HBV)<br>and Hepatitis C Virus (HCV) for molecular diagnostic platforms<br>listed in the package insert. This product is not intended to<br>replace manufacturer controls provided with the device. This<br>product is not intended for use in blood donor screening assays in<br>the US or Canada. | Amplichek II is intended for use as an external assayed quality<br>control material to monitor the performance of in vitro<br>laboratory nucleic acid testing procedures for the qualitative<br>detection of Methicillin Resistant Staphylococcus aureus,<br>Methicillin Sensitive Staphylococcus aureus, Clostridium<br>difficile and Vancomycin-resistant Enterococci performed on<br>Cepheid GeneXpert Systems. This product is not intended to<br>replace manufacturer controls provided with the device. This<br>product is only for use with assays and instruments listed in the<br>Representative Results Chart in this labeling. |
| Form | Liquid | Liquid |
| Levels | 4 Levels<br>(Negative and Positive L1, L2 and L3) | 4 Levels<br>(Negative and Positive L1, L2 and L3) |
| Preservatives | Contains preservatives | Contains preservatives |
| | 0.09% Sodium azide | 0.1% ProClin® 300 preservative |
| Stabilizers | Contains stabilizers | Contains stabilizers |
| Differences | | |
| Open Vial Claim | 7 days at 2 to 8°C or 3 vial entries whichever comes first | None |
| Matrix | Human plasma based | Aqueous buffered solution |
| Expected<br>Results | For use with quantitative assays<br>Lot specific results provided | For use with qualitative assays<br>Representative results provided |
| Storage(Unopen<br>ed) | Frozen (-20°C -70 °C) Until expiration date | 2 to 8°C until expiration date |
| Analytes | HIV-1<br>HBV<br>HCV | MRSA (Methicillin Resistant Staphylococcus aureus)<br>MSSA (Methicillin Sensitive Staphylococcus aureus)<br>Cdiff (Clostridium difficile)<br>VRE (Vancomycin-resistant Enterococci) |

#### 7.0 Statement of Supporting Data

Stability studies have been performed to determine the shelf life at -20 to -70 ℃, and open vial at claims at 2 to 8°C. Product claims are as follows:

- 7.1 Shelf Life at 20 to -70℃, all analytes will be stable for 16 months.

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- 7.2 The open vial stability claim for Amplichek I is 7 days or 3 vial entries whichever comes first, when stored tightly capped at 2 to 8°C
All supporting data is retained on file at Bio-Rad Laboratories.

### 8.0 Conclusion

Based on the performance characteristics indicated above, the Bio-Rad Amplichek I is substantially equivalent to the predicate device: Amplichek II DEN 150058